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Massive west african trial takes on deadly lassa fever with new drug cocktail

NCT ID NCT06212336

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large clinical trial in West Africa is testing several drugs—including favipiravir, ribavirin, dexamethasone, and a new drug called ARN-75039—to find a better treatment for Lassa fever, a viral disease that kills thousands each year. The study will enroll about 1,755 hospitalized patients and measure whether these drugs reduce death and organ failure compared to standard care. The goal is to find a safer and more effective option than the current treatment, ribavirin, which has serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Favipiravir, Ribavirin, Dexamethasone, ARN-75039
What this could lead to
If successful, this trial could identify a safer and more effective treatment for Lassa fever, potentially saving thousands of lives in West Africa.
What could go wrong
This is an early-to-mid stage trial, and the drugs may not prove more effective than current care. Ribavirin has known toxicity, and new drugs like ARN-75039 are still being tested for safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,755 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. General Inclusion criteria * Clinical disease with signs and symptoms suggestive for LF * Positive plasma LASV RT-PCR * Participant requires hospitalization per the local guidelines * Participant or their legally authorized representative is able and willing to sign the informed consent Exclusion criteria * Unwilling to provide informed consent * Positive pregnancy test * Unwilling to provide informed consent * History of allergic reaction or other contra-indication to ribavirin according to the Reference safety document * Received drug therapy for Lassa fever (excluding supportive care) prior to inclusion * Has received a vaccine against LF 2. Sub-protocols 2.1 Favipiravir high dose sub-protocol Inclusion criteria • Age ≥ 18 years old Exclusion criteria • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential) * Treatment contraindicated with favipiravir according to the Reference safety document * Pre-existing liver failure * Severe symptomatic gout/hyperuricemia * History of QT prolongation or arrhythmia or other cardiac disorders * PR interval ≥ 200 ms * Hypersensitivity to excipients * Inability to take oral drug (e.g. encephalopathy, severe vomiting) 2.2. Favipiravir-Ribavirin sub-protocol Inclusion criteria • Age ≥ 18 years old Exclusion criteria * Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential) * Treatment contraindicated with favipiravir according to the Reference safety document * Pre-existing liver failure * Severe symptomatic gout/hyperuricemia * History of QT prolongation or arrhythmia or other cardiac disorders * PR interval ≥ 200 ms * Hypersensitivity to excipients * Inability to take oral drug (e.g. encephalopathy, severe vomiting) 2.3. Dexamethasone sub-protocol Inclusion criteria • Age ≥ 12 years old Exclusion criteria • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential) • Known intolerance and contra-indications to ribavirin or dexamethasone • Patients who already received a corticosteroid within the preceding 7 days 2.4 ARN-75039 subprotocols Exclusion criteria • History of severe gastrointestinal disease • History of chronic generalized pruritus * History of severe chronic liver disease * History of severe cardiac disorder

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Conditions

The condition(s) this trial relates to.

Communicable Diseases, Emerging Lassa fever viral hemorrhagic fever

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abubakar Tafawa Balewa University Teaching Hospital

    NOT_YET_RECRUITING

    Bauchi, Nigeria

  • Federal Medical Center Owo

    RECRUITING

    Owo, Ondo State, Nigeria

  • Irrua Specialist Teaching Hospital

    RECRUITING

    Irrua, Edo, Nigeria

  • Phebe Hospital

    NOT_YET_RECRUITING

    Suacoco, Bong County, Liberia

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